Status:
SUSPENDED
Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
Lead Sponsor:
Aston University
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is to evaluate the effectiveness of E\>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress
Detailed Description
E-Eye is a medical device that has been specifically designed for treating dry eye syndrome due to meibomian gland dysfunction (MGD). This study is a prospective, single centred, interventional, rando...
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent and participate in the required study visit
- Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to MGD, defined by the following:
- OSDI score \>13 and
- NITBUT \<= 10sec
Exclusion
- No use of warm compresses, intense pulsed light therapy or other lid warming treatment in the past 6 Months
- Patients with greater 75% meibomian gland loss
- Presence of ocular pathology or systemic conditions other than previously diagnosed moderate or severe chronic dry eye and/or Sjogren's syndrome, that in the investigator's judgment may affect the testing for, or diagnosis of, dry eye if present
- Use of prescribed ocular topical medication (e.g., anti-hypertensive, steroid, Cyclosporin A, antibiotic) within the last 24 hours
- Artificial tear usage within 2 hours prior to study testing
- Other invasive ocular diagnostic testing within 2 hours prior to study testing
- Eye makeup present on the eye lid within 10 minutes prior to study testing
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 16 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04920396
Start Date
June 8 2021
End Date
December 16 2026
Last Update
April 23 2024
Active Locations (1)
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1
Market Mall Eye Clinic - Calgary, AB
Calgary, Alberta, Canada, AB T3A 0E2